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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT 2005-004029-24 |
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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
| Sanofi | INDUSTRY |
The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin/docetaxel | Drug | |||
| cisplatin/vinorelbine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Success of delivery treatment; data collected during chemotherapy treatment | ||
| Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Overall toxicity | ||
| Progression free survival and overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul R. Germonpre, MD PhD | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | Antwerp | 2020 | Belgium | ||
| University Hospital Antwerp |
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| Edegem |
| Antwerp |
| 2650 |
| Belgium |
| St Augustinus ziekenhuis | Wilrijk | Antwerp | 2610 | Belgium |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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